Status:
NOT_YET_RECRUITING
Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder
Lead Sponsor:
Lakshmi N Yatham
Conditions:
Bipolar II Depression
Eligibility:
All Genders
19-65 years
Phase:
PHASE3
Brief Summary
This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectivene...
Detailed Description
Bipolar disorders (BD) are lifelong conditions characterized by recurrent episodes of depression and (hypo)mania. Statistics Canada data indicate over a million Canadians are affected by this illness....
Eligibility Criteria
Inclusion
- You are male or female aged 19 to 65 years inclusive.
- You have a diagnosis of bipolar disorder type II, and are currently in a major depressive episode.
- You are willing, for the entire duration of the study, to practice highly effective methods of contraception (e.g., contraceptive pills, intrauterine device or system, vasectomy and tubal ligation, or double-barrier methods of contraception) OR agree to completely abstain from heterosexual intercourse. Females who do not have childbearing potential are required to be postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) OR surgically sterile.
- You have sufficient English language skills to understand, consent to, and comply with study requirements, study visits, and to return to the clinic for follow-up evaluations.
- Your current medications have been at a stable dose for two weeks prior to the dosing visit.
Exclusion
- You have a history of psychotic symptoms.
- You have a history of seizures.
- You have a current unstable or inadequately treated medical illness, especially cardiovascular illness, except for the current depression.
- You recently (i.e., within the past 6 weeks) started taking treatment for your acute bipolar depressive episode.
- You recently (i.e., within the past 8 weeks) began structured psychotherapy (e.g., cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).
- You have a history of nonresponse or intolerance to psilocybin.
- You have, in the past 6 months, used any psychedelic drugs, including ketamine, LSD, or psilocybin-containing mushrooms.
- You have a history of non-response to electroconvulsive therapy.
- You are pregnant or lactating.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06943573
Start Date
October 1 2025
End Date
December 1 2028
Last Update
August 27 2025
Active Locations (3)
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1
Djavad Mowafaghian Centre for Brain Health
Vancouver, British Columbia, Canada, V6T 1Z3
2
Department of Psychiatry, University of Ottawa, The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
3
Department of Psychiatry, University of Toronto, University Health Network,
Toronto, Ontario, Canada, M5T 2S8